Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

My CDMO Is A Constellation of Unified Skills. Is Yours?

A CDMO employs accomplished professionals, operates modern facilities, and still frustrates the heck out of you. Accumulated talent and capabilities are impressive, but closer examination reveals the problem lies between the lines of the CDMO’s work demarcations. Instead, you need your CDMO to operate as a constellation of unified skills. Chief Editor Louis Garguilo explores this "holistic pattern of work that forms an interconnected organization, and presents a clear picture of management and culture."

GUEST COLUMNISTS

What Europe's Draft Annex 22 Actually Asks Of Human Oversight Of AI
The European Commission and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) consulted on draft Annex 22, Artificial Intelligence. Here's what you should know.
How Is Your Glass Supplier Adapting To Europe's Energy Crisis?
Europe's glass manufacturers, including those making pharmaceutical lab glassware, have experienced a series of energy shocks. Many have adopted sustainability practices.
The EU Overhauls Pharma Laws: What You Need To Know
On Sept. 18, the Council of the EU published the almost-final text of a major overhaul of the EU pharmaceutical laws. The final binding text is expected to be published very soon.
September 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?
FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?
Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty
Geopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.
Is Your Supply Chain Ready For The End Of Class VI?
Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.
Beyond API Sourcing: Avoiding Supply Disruptions For Small Molecule Drugs
Supply resilience should be assessed across the complete drug product pathway rather than measured by the number of vendors listed in a procurement system.

PHARMA OUTSOURCING WHITE PAPERS

Designing, Selecting, And Developing Bioconjugates For Clinical Success
Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.

Difficult-To-Purify And Difficult-To-Filter Small Molecules
Poor filterability and stubborn impurities often trace back to the same molecular features, which changes how development teams approach scale-up for larger, structurally complex small molecules.
Choosing The Right CDMO For Substance Development And Manufacturing
Controlled substance programs demand licensing, closed-system custody, and inspection history well beyond GMP. Sponsors weighing partners must test technical depth against compliance infrastructure.
Advancing ADCs: From Concept To Commercialization
ADC programs move fastest when payload-linker strategy, route design, conjugation, and drug product are planned together, with timelines and scale-up capacity shaping choices from the earliest development stages.
Managing Risks With Potent Pharmaceutical Products
Manufacturing potent medications safely requires specialized containment, toxicology expertise, and strict contamination controls to ensure compliance, product quality, and worker safety.
Is Your API Right For A Soft Gel Capsule?
Soft gel delivery systems can enhance bioavailability, enable controlled release, support combination dosing, and handle potent compounds while improving stability and patient adherence.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

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EDITORIAL COLLECTIONS

Take a closer look at the decisions shaping biopharma outsourcing. Our Editorial Collections examine how organizations select CDMOs, manage external relationships, transfer processes, and weigh the business realities of outsourced development and manufacturing.

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